Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Camrelizumab + Apatinib | Experimental | Apatinib 250mg, po qd, and Camrelizumab 200mg, iv q2w as neoadjuvant treatment. 28 days as one cycle, for at least two cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab and Apatinib | Drug | All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ORR | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| R0/1 resection rate | R0/1 resection rate if operable | at the time of surgery |
| Disease control rate | DCR | at the time point of 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wang, M.D. | Contact | 86-021-64175590 | 65805 | neck130@hotmail.com |
| Nai-si Huang, M.D. | Contact | 86-021-64175590 | 67816 | huangnaisi@fudan.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D013514 | Surgical Procedures, Operative |
| D062005 | Biopsy, Large-Core Needle |
| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| surgery | Procedure | Perform surgery if operable after neoadjuvant therapy |
|
| core needle biopsy | Procedure | Perform core needle biopsy if inoperable after neoadjuvant therapy |
|
| Overall survival | OS | up to 3 years |
| Adverse Events | AEs | from the first drug administration to within 90 days after surgery |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D019411 |
| Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D011677 | Punctures |
| D008919 | Investigative Techniques |